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AMA: Patient mix has become less uninsured since 2012
Uninsured patients made up a smaller share of the average physician’s practice in 2016 than in 2012, according to a survey by the American Medical Association.
For the average practice in 2016, 6.1% of patients were uninsured, compared with 6.9% in 2012. That significant drop of 0.8 percentage points was accompanied by significant increases in the number of patients covered by Medicaid and by private insurance, the AMA said in a report released Oct. 30.
“The overall picture from new physician-reported data is of more patients covered and fewer uninsured, but the findings also indicate that the improvement along those lines was concentrated in states that expanded their Medicaid programs under the ACA,” said David O. Barbe, MD, AMA president.
In the 31 states and the District of Columbia that expanded Medicaid, the average patient share dropped from 6.4% uninsured in 2012 to 5.4% in 2016, which was significant. In the states that did not expand Medicaid, the average share of uninsured patients went from 8.0% to 7.4% over that period, a drop that did not reach significance, the AMA said.
The changes involving Medicaid itself were of somewhat greater magnitude, in both directions: nonexpansion states saw a smaller increase and expansion states had a larger increase. In nonexpansion states the average share of a practice’s patients covered by Medicaid basically held steady at 15.3% (there was actually a very slight increase, but the AMA reported the figures for both 2012 and 2016 as 15.3%). In expansion states, the average Medicaid share went from 16.2% to 17.6% – a statistically significant increase of 1.4 percentage points, the AMA analysis shows.
The AMA report covers data from its 2012 and 2016 Benchmark Surveys, which each year involved approximately 3,500 physicians in patient care who were not employed by the federal government.
Uninsured patients made up a smaller share of the average physician’s practice in 2016 than in 2012, according to a survey by the American Medical Association.
For the average practice in 2016, 6.1% of patients were uninsured, compared with 6.9% in 2012. That significant drop of 0.8 percentage points was accompanied by significant increases in the number of patients covered by Medicaid and by private insurance, the AMA said in a report released Oct. 30.
“The overall picture from new physician-reported data is of more patients covered and fewer uninsured, but the findings also indicate that the improvement along those lines was concentrated in states that expanded their Medicaid programs under the ACA,” said David O. Barbe, MD, AMA president.
In the 31 states and the District of Columbia that expanded Medicaid, the average patient share dropped from 6.4% uninsured in 2012 to 5.4% in 2016, which was significant. In the states that did not expand Medicaid, the average share of uninsured patients went from 8.0% to 7.4% over that period, a drop that did not reach significance, the AMA said.
The changes involving Medicaid itself were of somewhat greater magnitude, in both directions: nonexpansion states saw a smaller increase and expansion states had a larger increase. In nonexpansion states the average share of a practice’s patients covered by Medicaid basically held steady at 15.3% (there was actually a very slight increase, but the AMA reported the figures for both 2012 and 2016 as 15.3%). In expansion states, the average Medicaid share went from 16.2% to 17.6% – a statistically significant increase of 1.4 percentage points, the AMA analysis shows.
The AMA report covers data from its 2012 and 2016 Benchmark Surveys, which each year involved approximately 3,500 physicians in patient care who were not employed by the federal government.
Uninsured patients made up a smaller share of the average physician’s practice in 2016 than in 2012, according to a survey by the American Medical Association.
For the average practice in 2016, 6.1% of patients were uninsured, compared with 6.9% in 2012. That significant drop of 0.8 percentage points was accompanied by significant increases in the number of patients covered by Medicaid and by private insurance, the AMA said in a report released Oct. 30.
“The overall picture from new physician-reported data is of more patients covered and fewer uninsured, but the findings also indicate that the improvement along those lines was concentrated in states that expanded their Medicaid programs under the ACA,” said David O. Barbe, MD, AMA president.
In the 31 states and the District of Columbia that expanded Medicaid, the average patient share dropped from 6.4% uninsured in 2012 to 5.4% in 2016, which was significant. In the states that did not expand Medicaid, the average share of uninsured patients went from 8.0% to 7.4% over that period, a drop that did not reach significance, the AMA said.
The changes involving Medicaid itself were of somewhat greater magnitude, in both directions: nonexpansion states saw a smaller increase and expansion states had a larger increase. In nonexpansion states the average share of a practice’s patients covered by Medicaid basically held steady at 15.3% (there was actually a very slight increase, but the AMA reported the figures for both 2012 and 2016 as 15.3%). In expansion states, the average Medicaid share went from 16.2% to 17.6% – a statistically significant increase of 1.4 percentage points, the AMA analysis shows.
The AMA report covers data from its 2012 and 2016 Benchmark Surveys, which each year involved approximately 3,500 physicians in patient care who were not employed by the federal government.
Study highlights disparities in U.S. lupus mortality
Mortality from systemic lupus erythematosus has declined since 1968 in the United States, but not as markedly as rates of death from other causes, according to a study in Annals of Internal Medicine.
Furthermore, systemic lupus erythematosus (SLE) mortality varied significantly by sex, race, and geographic region, noted Eric Y. Yen, MD, and his associates at the University of California, Los Angeles. Mortality from SLE was highest among females, black individuals, and those who lived in the South. Multivariable analyses confirmed that sex, race, and geographic region were independent risk factors for SLE mortality and that race modified relationships among SLE mortality, sex, and geographic region.
Between 1968 and 2013, there were 50,249 deaths from SLE and more than 100.8 million deaths from other causes in the United States, the researchers said. Mortality from other causes continuously dropped over the study period, but SLE mortality dropped only between 1968 and 1975 before rising continuously for 24 years. Only in 1999 did SLE mortality begin to fall again. Consequently, the ratio of SLE mortality to mortality from other causes rose by 34.6% overall between 1968 and 2013, and rose by 62.5% among blacks and by 58.6% among southerners.
After the researchers accounted for age, sex, race or ethnicity, and geographic region, the risk of death from SLE dropped significantly during 2004 through 2008, compared with 1999 through 2003, and declined even more between 2009 and 2013. Female sex, racial or ethnic minority status, residing in the South or West, and being older than 65 years all independently increased the risk of dying from SLE.
Although the South had the highest SLE mortality among whites, the West had the highest SLE mortality among all other races and ethnicities, the investigators determined. Previous research has identified pockets of increased SLE mortality in Alabama, Arkansas, Louisiana, and New Mexico, and has shown that poverty is a stronger predictor of SLE mortality than race, they noted. “Geographic differences in the quality of care of patients with lupus nephritis have also been reported, with more patients in the Northeast receiving standard-of-care medications,” they wrote. “Interactions between genetic and non-genetic factors associated with race/ethnicity and geographic differences in environment, such as increased sunlight exposure, socioeconomic factors, and access to medical care, might also influence SLE mortality.”
The National Institutes of Health, the Lupus Foundation of America, and the Rheumatology Research Foundation funded the study. The investigators reported having no conflicts of interest.
Mortality from systemic lupus erythematosus has declined since 1968 in the United States, but not as markedly as rates of death from other causes, according to a study in Annals of Internal Medicine.
Furthermore, systemic lupus erythematosus (SLE) mortality varied significantly by sex, race, and geographic region, noted Eric Y. Yen, MD, and his associates at the University of California, Los Angeles. Mortality from SLE was highest among females, black individuals, and those who lived in the South. Multivariable analyses confirmed that sex, race, and geographic region were independent risk factors for SLE mortality and that race modified relationships among SLE mortality, sex, and geographic region.
Between 1968 and 2013, there were 50,249 deaths from SLE and more than 100.8 million deaths from other causes in the United States, the researchers said. Mortality from other causes continuously dropped over the study period, but SLE mortality dropped only between 1968 and 1975 before rising continuously for 24 years. Only in 1999 did SLE mortality begin to fall again. Consequently, the ratio of SLE mortality to mortality from other causes rose by 34.6% overall between 1968 and 2013, and rose by 62.5% among blacks and by 58.6% among southerners.
After the researchers accounted for age, sex, race or ethnicity, and geographic region, the risk of death from SLE dropped significantly during 2004 through 2008, compared with 1999 through 2003, and declined even more between 2009 and 2013. Female sex, racial or ethnic minority status, residing in the South or West, and being older than 65 years all independently increased the risk of dying from SLE.
Although the South had the highest SLE mortality among whites, the West had the highest SLE mortality among all other races and ethnicities, the investigators determined. Previous research has identified pockets of increased SLE mortality in Alabama, Arkansas, Louisiana, and New Mexico, and has shown that poverty is a stronger predictor of SLE mortality than race, they noted. “Geographic differences in the quality of care of patients with lupus nephritis have also been reported, with more patients in the Northeast receiving standard-of-care medications,” they wrote. “Interactions between genetic and non-genetic factors associated with race/ethnicity and geographic differences in environment, such as increased sunlight exposure, socioeconomic factors, and access to medical care, might also influence SLE mortality.”
The National Institutes of Health, the Lupus Foundation of America, and the Rheumatology Research Foundation funded the study. The investigators reported having no conflicts of interest.
Mortality from systemic lupus erythematosus has declined since 1968 in the United States, but not as markedly as rates of death from other causes, according to a study in Annals of Internal Medicine.
Furthermore, systemic lupus erythematosus (SLE) mortality varied significantly by sex, race, and geographic region, noted Eric Y. Yen, MD, and his associates at the University of California, Los Angeles. Mortality from SLE was highest among females, black individuals, and those who lived in the South. Multivariable analyses confirmed that sex, race, and geographic region were independent risk factors for SLE mortality and that race modified relationships among SLE mortality, sex, and geographic region.
Between 1968 and 2013, there were 50,249 deaths from SLE and more than 100.8 million deaths from other causes in the United States, the researchers said. Mortality from other causes continuously dropped over the study period, but SLE mortality dropped only between 1968 and 1975 before rising continuously for 24 years. Only in 1999 did SLE mortality begin to fall again. Consequently, the ratio of SLE mortality to mortality from other causes rose by 34.6% overall between 1968 and 2013, and rose by 62.5% among blacks and by 58.6% among southerners.
After the researchers accounted for age, sex, race or ethnicity, and geographic region, the risk of death from SLE dropped significantly during 2004 through 2008, compared with 1999 through 2003, and declined even more between 2009 and 2013. Female sex, racial or ethnic minority status, residing in the South or West, and being older than 65 years all independently increased the risk of dying from SLE.
Although the South had the highest SLE mortality among whites, the West had the highest SLE mortality among all other races and ethnicities, the investigators determined. Previous research has identified pockets of increased SLE mortality in Alabama, Arkansas, Louisiana, and New Mexico, and has shown that poverty is a stronger predictor of SLE mortality than race, they noted. “Geographic differences in the quality of care of patients with lupus nephritis have also been reported, with more patients in the Northeast receiving standard-of-care medications,” they wrote. “Interactions between genetic and non-genetic factors associated with race/ethnicity and geographic differences in environment, such as increased sunlight exposure, socioeconomic factors, and access to medical care, might also influence SLE mortality.”
The National Institutes of Health, the Lupus Foundation of America, and the Rheumatology Research Foundation funded the study. The investigators reported having no conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Mortality from systemic lupus erythematosus has declined since 1968, but not as markedly as rates of death from other causes.
Major finding: The ratio of SLE mortality to mortality from other causes rose by nearly 35% between 1968 and 2013.
Data source: Analyses of the Centers for Disease Control and Prevention’s National Vital Statistics System and CDC WONDER.
Disclosures: The National Institutes of Health, the Lupus Foundation of America, and the Rheumatology Research Foundation funded the study. The investigators reported having no conflicts of interest.
Business law critical to your practice
It is no surprise that the law is playing an ever more important role in the practice of medicine. Concerns about legal issues are a source of stress for ObGyns, including increasing worries about the economics of professional liability, the anxiety of defending a legal claim, and ambiguity about what is required for compliance.1 In this article my goal is to demystify some of the most important legal principles affecting your practice and provide suggestions for avoiding legal problems.
Medical malpractice: A form of negligence
Most ObGyns instinctively think first of medical malpractice when “legal problems” are mentioned—not an unreasonable response because obstetrics has a high incidence of malpractice claims. In one study, 77% of the American College of Obstetricians and Gynecologists (ACOG) Fellows reported that they have been sued.2
At its core, malpractice is a form of negligence, or, medical practice that falls below the quality of care that a reasonably careful practitioner would provide under the circumstances. When practice falls below that “standard of care,” and it causes injury, there may be malpractice liability. Insurance usually covers the cost of defending malpractice lawsuits and paying liability (although liability is the result of a minority of malpractice suits). There are, however, collateral consequences, including the time, stress, and disruption associated with defending the suit. In addition, malpractice may trigger review by the institutions with which the physician is associated, or in extreme cases, by licensing authorities. Large malpractice settlements or verdicts must be reported to the National Practitioner Database (sometimes colloquially referred to the “problem physician” database) or a similar state database.
This article is the third installment of the new series, "The Business of Medicine," edited by Joseph Sanfilippo, MD, MBA. In September, David Kim, MD, MBA, MPH, offered marketing strategies using social media. Last month, Dr. Sanfilippo presented ways to ensure patient satisfaction and service excellence in your practice. Watch next time for "Accounting 101." Other featured topics will include investing in your practice, billing and coding, gaining the competitive advantage, understanding "best practices," and striving for cost-effective care.
Related article:
Who is liable when a surgical error occurs?
Regulation and reimbursement (“compliance”) policies
The practice of medicine is closely regulated by federal and state bodies. Many regulations apply through reimbursement policies related to Medicare and Medicaid. While malpractice liability may, at worst, result in a financial award (with the cost of defense and any award paid by insurance), regulatory problems may result in a number of unpleasant consequences, most of which are not covered by insurance. In addition to loss of reimbursement, civil penalties (even criminalpenalties in extreme cases), loss of hospital privileges, licensure discipline, and loss of Medicare-Medicaid eligibility may result from regulatory noncompliance.3
There are multivolume sets discussing these legal requirements, so here we will look only at a tiny tip of the regulatory iceberg by mentioning some common regulatory areas.
Fraud and abuse laws refer to a bundle of federal (and some state) statutes and regulations that are intended to ensure that public-funded programs such as Medicare and Medicaid are not cheated or overpaying for services. It is a violation to provide low-quality services to government-funded programs. Proper payment and coding and ensuring that services were actually performed by the professional listed (not someone else) are examples of traps for the unwary. Submitting inaccurate records may result in action to recover incorrect payments and in civil penalties. In extreme cases where there is intentional misrepresentation, there have been criminal charges and loss of future Medicare-Medicaid eligibility.
Anti-kickback, self-referral, and Stark limitations are intended to avoid unnecessary or overpriced services. When someone is receiving a benefit for ordering or recommending a product or service, it is reasonable to expect that an incentive might affect the decision to order it, likely resulting in unnecessary or suboptimal services. It is illegal to receive a kickback for using, ordering, or recommending a product or service (a pharmaceutical company could not pay a physician $10 for each prescription written for its product). It is also illegal for physicians to refer patients to other entities in which they have a financial interest (a physician could not refer a patient to a lab in which the physician has partial ownership). The Stark laws and state prohibitions on self-referral have complex series of “safe harbor” exceptions in an ocean of prohibitions.4
HIPAA and confidentiality regulations are intended to protect patient privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has extensive regulations concerning both privacy and security. The medical community is well-versed in HIPAA regulations and sensitive (perhaps hypersensitive) to its requirements. Most states have patient privacy regulations that apply in addition to HIPAA and are commonly less well known.
Protecting patient confidentiality is an ethical, legal, and licensure obligation. Protecting patient confidentiality is, therefore, general duty and not tied to a specific federal program.5
Related article:
Patient with a breast mass: Why did she pursue litigation?
Insurance Fraud is the private side of fraud and abuse. Submitting private insurance claims that are false or a misrepresentation of service is generally a violation of the contract between the provider and the insurance company. It may also be a crime—it is, after all, a form of theft. Serious fraud may result in the loss of the license to practice.
The False Claims Act and Whistleblower laws make it a civil offense (and, in extreme cases, a criminal offense), to present to the government a false claim for payment of services. It may be false in the sense that the service was not provided or in the sense that service was of inadequate quality. These statutes (both federal and state) also allow for a private whistleblower to receive some of the proceeds if he or she helps the government recoup wrongful payments. Disgruntled former employees are a common source of whistleblowing.6
Abuse-reporting statutes are part of every state’s law but vary considerably. They require certain professions, including physicians, to report known or suspected abuse of children, dependent adults, and often, other groups. The failure to make required reports can result in civil liability or even (rarely) criminal charges.
Read about how organizational law affects ObGyns.
How organizational and commercial law affects ObGyns
Physicians are generally members of organizations that are engaged in the business of health care (even nonprofit organizations have business interests). There are 2 major legal building blocks of these business relationships: contracts and agency.7
Contracts are agreements between 2 or more persons or entities that carry with them legally enforceable obligations. The 3 common elements are an offer by one party, acceptance by another, and consideration (exchanging one thing of value for another). Contracts are binding in the sense that, if there is a breach of the promise by one party, the other party may seek monetary damages for the loss of the benefit of the bargain (and in limited circumstances, require that the contract be performed).
Agency is essentially the mechanism that allows a person to legally work for or on behalf of another. A “principal” authorizes an agent to take actions for, and bind, the principal. All employment, partnership, and “agent” relationships create an agency. The principal is generally responsible for the actions of the agent—at least within the scope of the agent’s authority. For example, the principal is responsible for the torts (civil liability resulting from the breach of a socially imposed duty, but generally not arising from a contract) of an agent doing the principal’s business. The agent has the obligation to act in good faith for the benefit of the principal and to abide by the instructions of the principal.
Corporate structures
There are a variety of corporate organizational structures; the basic types are corporations, partnerships, and unincorporated associations. These generally are available to nonprofit and for-profit organizations. As a general matter, corporations limit the owners’ personal liability; partnerships have tax advantages. A number of laws now allow the creation of entities that have both liability and tax advantages (subchapter S corporations, limited liability companies, and limited liability partnerships).
Other areas of business law
Employment law, which now affects almost every aspect of hiring, dismissal, payment, and fringe benefits, is not a single law but a series of state and federal statutes, regulations, and court decisions.8
Competition is regulated through a number of antitrust laws as well as fair business practices. These affect the ability of health care entities to merge, fix prices, and split markets.9
There are literally hundreds of other laws that affect the way health care entities can operate. Conducting a careful compliance review is of considerable importance.10
Read about the dos and don’ts of preventive law.
Dos and don’ts of preventive law
The business of medicine is subject to many laws and keeping track of all of these is generally beyond the expertise of the ObGyn. Here are a few practical suggestions for thriving in this legal milieu.
Understanding the law
DO establish an ongoing relationship with an attorney you can trust who is knowledgeable in health law. Consult with this attorney not only on an as-needed basis but also for an “annual checkup” of legal issues affecting your practice.
DON’T guess what the law is. Laws vary from state to state and change frequently. Taking curbstone advice or suggestions from a podcast is a good way to develop problems.
Error reduction
DO take risk management seriously. Implement plans to improve patient safety and reduce errors.11
DON’T ignore angry or hostile patients. Their hostility may be directed at you—an undesirable state. The same goes for disgruntled (or former) employees, who may become whistleblowers.
Insurance
DO review your insurance coverage annually, preferably with an expert or your attorney. Insurance policies and your insurance needs change frequently.
DON’T assume you have all the insurance you need or that insurance will cover all legal claims arising from your practice. Intentional torts, some antitrust claims, licensure discipline, and civil fines, for example, may not be covered.
Informed consent and ethics
DO use the informed consent process as a means of improving communication between you and your patients to address their concerns and discuss expectations. Autonomy is a basic ethical value of medicine and informed consent helps to achieve that goal.
DON’T ignore ethics. Ethical obligations are not just essential to maintaining a license, hospital privileges, and professional standing.12 They also help guide you toward good practice that avoids liability.
Related articles:
Informed consent: The more you know, the more you and your patient are protected
Compliance, disputes, and arbitration
DO engage in continuing compliance review. That includes understanding the contracts and professional arrangements in which you practice and all of the requirements of third-party payers (especially government entities). There are a wide range of other compliance obligations that require ongoing attention.
DON’T sign arbitration agreements without understanding exactly what you are agreeing to. There are advantages to arbitration,13 but there are disadvantages, too.14 The courts generally enforce arbitration agreements, even ones that are unfair or one-sided.15
The law need not be a mystery or the enemy. Preventive law, like preventive medicine, can make all the difference.16
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Carpentieri AM, Lumalcuri JJ, Shaw J, Joseph GF Jr. Overview of the 2015 American Congress of Obstetricians and Gynecologists’ Survey on Professional Liability. https://www.acog.org/-/media/Departments/Professional-Liability/2015PLSurveyNationalSummary11315.pdf?dmc=1&ts=20171003T150028497. Published November 3, 2015. Accessed October 3, 2017.
- American College of Obstetrics and Gynecology Committee on Professional Liability. ACOG Opinion No. 551: Coping with the stress of professional liability litigation. Obstet Gynecol. 2013;121(1):220–222.
- Teitlebaum JB, Wilensky SE. Essential of Health Policy and Law. 2nd ed. Burlington, MA: Jones & Bartlett Learning; 2012:31–43, 127–134.
- Fabrikant R, Kalb PE, Bucy PH, Hopson MD. Health Care Fraud: Enforcement and Compliance. Newark, NJ: Law Journal Press; 2017;4:44–140.
- Health Information Privacy. Department of Health and Human Services. https://www.hhs.gov/hipaa. Updated 2017. Accessed October 3, 2017.
- Kropf S. Healthcare Fraud 101: The False Claims Act. ObGyn.Net. http://www.obgyn.net/blog/healthcare-fraud-101-false-claims-act. Published March 10, 2017. Accessed October 3, 2017.
- Smith SR, Sanfilippo JS. Applied Business Law. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:91–126.
- Todd MK. The Physician Employment Contract Handbook: A Guide to Structuring Equitable Arrangements. 2nd ed. New York, NY: Productivity Press; 2011:67–77, 93–118.
- Federal Trade Commission. Competition in the Health Care Marketplace. https://www.ftc.gov/tips-advice/competition-guidance/industry-guidance/health-care. Updated 2017. Accessed October 3, 2017.
- Shwayder JM. What is new in medical-legal issues in obstetrics and gynecology?: Best articles from the past 2 years. Obstet Gynecol. 2016;128(6):1441–1442.
- Sanfilippo JS, Smith SR. Risk Management. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:277–298.
- Smith SR, Sanfilippo JS. Ethics and the Business of the Healthcare Professional. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:71–89.
- Knag PE, Kagan DJ. Why arbitration is the preferred dispute resolution vehicle for most integrated delivery system disputes. Dispute Resolution J. 2016;71(3):127–137.
- Larson DA, Dahl D. Medical malpractice arbitration: Not business as usual. Yearbook Arbitration Mediation. 2016;8:69–92.
- Trantina TL. What law applies to an agreement to arbitrate? American Bar Association. Dispute Resolution Magazine. Fall 2015:29–31.
- Curran M. Preventative law: Interdisciplinary from medical-legal partnership. NYU Rev Law Social Change. 2014;38(4):595–606.
Mr. Smith is Professor Emeritus of Law and Dean Emeritus at California Western School of Law, San Diego, California. He is an OBG
The author reports no financial relationships relevant to this article.
Mr. Smith is Professor Emeritus of Law and Dean Emeritus at California Western School of Law, San Diego, California. He is an OBG
The author reports no financial relationships relevant to this article.
Mr. Smith is Professor Emeritus of Law and Dean Emeritus at California Western School of Law, San Diego, California. He is an OBG
The author reports no financial relationships relevant to this article.
It is no surprise that the law is playing an ever more important role in the practice of medicine. Concerns about legal issues are a source of stress for ObGyns, including increasing worries about the economics of professional liability, the anxiety of defending a legal claim, and ambiguity about what is required for compliance.1 In this article my goal is to demystify some of the most important legal principles affecting your practice and provide suggestions for avoiding legal problems.
Medical malpractice: A form of negligence
Most ObGyns instinctively think first of medical malpractice when “legal problems” are mentioned—not an unreasonable response because obstetrics has a high incidence of malpractice claims. In one study, 77% of the American College of Obstetricians and Gynecologists (ACOG) Fellows reported that they have been sued.2
At its core, malpractice is a form of negligence, or, medical practice that falls below the quality of care that a reasonably careful practitioner would provide under the circumstances. When practice falls below that “standard of care,” and it causes injury, there may be malpractice liability. Insurance usually covers the cost of defending malpractice lawsuits and paying liability (although liability is the result of a minority of malpractice suits). There are, however, collateral consequences, including the time, stress, and disruption associated with defending the suit. In addition, malpractice may trigger review by the institutions with which the physician is associated, or in extreme cases, by licensing authorities. Large malpractice settlements or verdicts must be reported to the National Practitioner Database (sometimes colloquially referred to the “problem physician” database) or a similar state database.
This article is the third installment of the new series, "The Business of Medicine," edited by Joseph Sanfilippo, MD, MBA. In September, David Kim, MD, MBA, MPH, offered marketing strategies using social media. Last month, Dr. Sanfilippo presented ways to ensure patient satisfaction and service excellence in your practice. Watch next time for "Accounting 101." Other featured topics will include investing in your practice, billing and coding, gaining the competitive advantage, understanding "best practices," and striving for cost-effective care.
Related article:
Who is liable when a surgical error occurs?
Regulation and reimbursement (“compliance”) policies
The practice of medicine is closely regulated by federal and state bodies. Many regulations apply through reimbursement policies related to Medicare and Medicaid. While malpractice liability may, at worst, result in a financial award (with the cost of defense and any award paid by insurance), regulatory problems may result in a number of unpleasant consequences, most of which are not covered by insurance. In addition to loss of reimbursement, civil penalties (even criminalpenalties in extreme cases), loss of hospital privileges, licensure discipline, and loss of Medicare-Medicaid eligibility may result from regulatory noncompliance.3
There are multivolume sets discussing these legal requirements, so here we will look only at a tiny tip of the regulatory iceberg by mentioning some common regulatory areas.
Fraud and abuse laws refer to a bundle of federal (and some state) statutes and regulations that are intended to ensure that public-funded programs such as Medicare and Medicaid are not cheated or overpaying for services. It is a violation to provide low-quality services to government-funded programs. Proper payment and coding and ensuring that services were actually performed by the professional listed (not someone else) are examples of traps for the unwary. Submitting inaccurate records may result in action to recover incorrect payments and in civil penalties. In extreme cases where there is intentional misrepresentation, there have been criminal charges and loss of future Medicare-Medicaid eligibility.
Anti-kickback, self-referral, and Stark limitations are intended to avoid unnecessary or overpriced services. When someone is receiving a benefit for ordering or recommending a product or service, it is reasonable to expect that an incentive might affect the decision to order it, likely resulting in unnecessary or suboptimal services. It is illegal to receive a kickback for using, ordering, or recommending a product or service (a pharmaceutical company could not pay a physician $10 for each prescription written for its product). It is also illegal for physicians to refer patients to other entities in which they have a financial interest (a physician could not refer a patient to a lab in which the physician has partial ownership). The Stark laws and state prohibitions on self-referral have complex series of “safe harbor” exceptions in an ocean of prohibitions.4
HIPAA and confidentiality regulations are intended to protect patient privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has extensive regulations concerning both privacy and security. The medical community is well-versed in HIPAA regulations and sensitive (perhaps hypersensitive) to its requirements. Most states have patient privacy regulations that apply in addition to HIPAA and are commonly less well known.
Protecting patient confidentiality is an ethical, legal, and licensure obligation. Protecting patient confidentiality is, therefore, general duty and not tied to a specific federal program.5
Related article:
Patient with a breast mass: Why did she pursue litigation?
Insurance Fraud is the private side of fraud and abuse. Submitting private insurance claims that are false or a misrepresentation of service is generally a violation of the contract between the provider and the insurance company. It may also be a crime—it is, after all, a form of theft. Serious fraud may result in the loss of the license to practice.
The False Claims Act and Whistleblower laws make it a civil offense (and, in extreme cases, a criminal offense), to present to the government a false claim for payment of services. It may be false in the sense that the service was not provided or in the sense that service was of inadequate quality. These statutes (both federal and state) also allow for a private whistleblower to receive some of the proceeds if he or she helps the government recoup wrongful payments. Disgruntled former employees are a common source of whistleblowing.6
Abuse-reporting statutes are part of every state’s law but vary considerably. They require certain professions, including physicians, to report known or suspected abuse of children, dependent adults, and often, other groups. The failure to make required reports can result in civil liability or even (rarely) criminal charges.
Read about how organizational law affects ObGyns.
How organizational and commercial law affects ObGyns
Physicians are generally members of organizations that are engaged in the business of health care (even nonprofit organizations have business interests). There are 2 major legal building blocks of these business relationships: contracts and agency.7
Contracts are agreements between 2 or more persons or entities that carry with them legally enforceable obligations. The 3 common elements are an offer by one party, acceptance by another, and consideration (exchanging one thing of value for another). Contracts are binding in the sense that, if there is a breach of the promise by one party, the other party may seek monetary damages for the loss of the benefit of the bargain (and in limited circumstances, require that the contract be performed).
Agency is essentially the mechanism that allows a person to legally work for or on behalf of another. A “principal” authorizes an agent to take actions for, and bind, the principal. All employment, partnership, and “agent” relationships create an agency. The principal is generally responsible for the actions of the agent—at least within the scope of the agent’s authority. For example, the principal is responsible for the torts (civil liability resulting from the breach of a socially imposed duty, but generally not arising from a contract) of an agent doing the principal’s business. The agent has the obligation to act in good faith for the benefit of the principal and to abide by the instructions of the principal.
Corporate structures
There are a variety of corporate organizational structures; the basic types are corporations, partnerships, and unincorporated associations. These generally are available to nonprofit and for-profit organizations. As a general matter, corporations limit the owners’ personal liability; partnerships have tax advantages. A number of laws now allow the creation of entities that have both liability and tax advantages (subchapter S corporations, limited liability companies, and limited liability partnerships).
Other areas of business law
Employment law, which now affects almost every aspect of hiring, dismissal, payment, and fringe benefits, is not a single law but a series of state and federal statutes, regulations, and court decisions.8
Competition is regulated through a number of antitrust laws as well as fair business practices. These affect the ability of health care entities to merge, fix prices, and split markets.9
There are literally hundreds of other laws that affect the way health care entities can operate. Conducting a careful compliance review is of considerable importance.10
Read about the dos and don’ts of preventive law.
Dos and don’ts of preventive law
The business of medicine is subject to many laws and keeping track of all of these is generally beyond the expertise of the ObGyn. Here are a few practical suggestions for thriving in this legal milieu.
Understanding the law
DO establish an ongoing relationship with an attorney you can trust who is knowledgeable in health law. Consult with this attorney not only on an as-needed basis but also for an “annual checkup” of legal issues affecting your practice.
DON’T guess what the law is. Laws vary from state to state and change frequently. Taking curbstone advice or suggestions from a podcast is a good way to develop problems.
Error reduction
DO take risk management seriously. Implement plans to improve patient safety and reduce errors.11
DON’T ignore angry or hostile patients. Their hostility may be directed at you—an undesirable state. The same goes for disgruntled (or former) employees, who may become whistleblowers.
Insurance
DO review your insurance coverage annually, preferably with an expert or your attorney. Insurance policies and your insurance needs change frequently.
DON’T assume you have all the insurance you need or that insurance will cover all legal claims arising from your practice. Intentional torts, some antitrust claims, licensure discipline, and civil fines, for example, may not be covered.
Informed consent and ethics
DO use the informed consent process as a means of improving communication between you and your patients to address their concerns and discuss expectations. Autonomy is a basic ethical value of medicine and informed consent helps to achieve that goal.
DON’T ignore ethics. Ethical obligations are not just essential to maintaining a license, hospital privileges, and professional standing.12 They also help guide you toward good practice that avoids liability.
Related articles:
Informed consent: The more you know, the more you and your patient are protected
Compliance, disputes, and arbitration
DO engage in continuing compliance review. That includes understanding the contracts and professional arrangements in which you practice and all of the requirements of third-party payers (especially government entities). There are a wide range of other compliance obligations that require ongoing attention.
DON’T sign arbitration agreements without understanding exactly what you are agreeing to. There are advantages to arbitration,13 but there are disadvantages, too.14 The courts generally enforce arbitration agreements, even ones that are unfair or one-sided.15
The law need not be a mystery or the enemy. Preventive law, like preventive medicine, can make all the difference.16
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
It is no surprise that the law is playing an ever more important role in the practice of medicine. Concerns about legal issues are a source of stress for ObGyns, including increasing worries about the economics of professional liability, the anxiety of defending a legal claim, and ambiguity about what is required for compliance.1 In this article my goal is to demystify some of the most important legal principles affecting your practice and provide suggestions for avoiding legal problems.
Medical malpractice: A form of negligence
Most ObGyns instinctively think first of medical malpractice when “legal problems” are mentioned—not an unreasonable response because obstetrics has a high incidence of malpractice claims. In one study, 77% of the American College of Obstetricians and Gynecologists (ACOG) Fellows reported that they have been sued.2
At its core, malpractice is a form of negligence, or, medical practice that falls below the quality of care that a reasonably careful practitioner would provide under the circumstances. When practice falls below that “standard of care,” and it causes injury, there may be malpractice liability. Insurance usually covers the cost of defending malpractice lawsuits and paying liability (although liability is the result of a minority of malpractice suits). There are, however, collateral consequences, including the time, stress, and disruption associated with defending the suit. In addition, malpractice may trigger review by the institutions with which the physician is associated, or in extreme cases, by licensing authorities. Large malpractice settlements or verdicts must be reported to the National Practitioner Database (sometimes colloquially referred to the “problem physician” database) or a similar state database.
This article is the third installment of the new series, "The Business of Medicine," edited by Joseph Sanfilippo, MD, MBA. In September, David Kim, MD, MBA, MPH, offered marketing strategies using social media. Last month, Dr. Sanfilippo presented ways to ensure patient satisfaction and service excellence in your practice. Watch next time for "Accounting 101." Other featured topics will include investing in your practice, billing and coding, gaining the competitive advantage, understanding "best practices," and striving for cost-effective care.
Related article:
Who is liable when a surgical error occurs?
Regulation and reimbursement (“compliance”) policies
The practice of medicine is closely regulated by federal and state bodies. Many regulations apply through reimbursement policies related to Medicare and Medicaid. While malpractice liability may, at worst, result in a financial award (with the cost of defense and any award paid by insurance), regulatory problems may result in a number of unpleasant consequences, most of which are not covered by insurance. In addition to loss of reimbursement, civil penalties (even criminalpenalties in extreme cases), loss of hospital privileges, licensure discipline, and loss of Medicare-Medicaid eligibility may result from regulatory noncompliance.3
There are multivolume sets discussing these legal requirements, so here we will look only at a tiny tip of the regulatory iceberg by mentioning some common regulatory areas.
Fraud and abuse laws refer to a bundle of federal (and some state) statutes and regulations that are intended to ensure that public-funded programs such as Medicare and Medicaid are not cheated or overpaying for services. It is a violation to provide low-quality services to government-funded programs. Proper payment and coding and ensuring that services were actually performed by the professional listed (not someone else) are examples of traps for the unwary. Submitting inaccurate records may result in action to recover incorrect payments and in civil penalties. In extreme cases where there is intentional misrepresentation, there have been criminal charges and loss of future Medicare-Medicaid eligibility.
Anti-kickback, self-referral, and Stark limitations are intended to avoid unnecessary or overpriced services. When someone is receiving a benefit for ordering or recommending a product or service, it is reasonable to expect that an incentive might affect the decision to order it, likely resulting in unnecessary or suboptimal services. It is illegal to receive a kickback for using, ordering, or recommending a product or service (a pharmaceutical company could not pay a physician $10 for each prescription written for its product). It is also illegal for physicians to refer patients to other entities in which they have a financial interest (a physician could not refer a patient to a lab in which the physician has partial ownership). The Stark laws and state prohibitions on self-referral have complex series of “safe harbor” exceptions in an ocean of prohibitions.4
HIPAA and confidentiality regulations are intended to protect patient privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has extensive regulations concerning both privacy and security. The medical community is well-versed in HIPAA regulations and sensitive (perhaps hypersensitive) to its requirements. Most states have patient privacy regulations that apply in addition to HIPAA and are commonly less well known.
Protecting patient confidentiality is an ethical, legal, and licensure obligation. Protecting patient confidentiality is, therefore, general duty and not tied to a specific federal program.5
Related article:
Patient with a breast mass: Why did she pursue litigation?
Insurance Fraud is the private side of fraud and abuse. Submitting private insurance claims that are false or a misrepresentation of service is generally a violation of the contract between the provider and the insurance company. It may also be a crime—it is, after all, a form of theft. Serious fraud may result in the loss of the license to practice.
The False Claims Act and Whistleblower laws make it a civil offense (and, in extreme cases, a criminal offense), to present to the government a false claim for payment of services. It may be false in the sense that the service was not provided or in the sense that service was of inadequate quality. These statutes (both federal and state) also allow for a private whistleblower to receive some of the proceeds if he or she helps the government recoup wrongful payments. Disgruntled former employees are a common source of whistleblowing.6
Abuse-reporting statutes are part of every state’s law but vary considerably. They require certain professions, including physicians, to report known or suspected abuse of children, dependent adults, and often, other groups. The failure to make required reports can result in civil liability or even (rarely) criminal charges.
Read about how organizational law affects ObGyns.
How organizational and commercial law affects ObGyns
Physicians are generally members of organizations that are engaged in the business of health care (even nonprofit organizations have business interests). There are 2 major legal building blocks of these business relationships: contracts and agency.7
Contracts are agreements between 2 or more persons or entities that carry with them legally enforceable obligations. The 3 common elements are an offer by one party, acceptance by another, and consideration (exchanging one thing of value for another). Contracts are binding in the sense that, if there is a breach of the promise by one party, the other party may seek monetary damages for the loss of the benefit of the bargain (and in limited circumstances, require that the contract be performed).
Agency is essentially the mechanism that allows a person to legally work for or on behalf of another. A “principal” authorizes an agent to take actions for, and bind, the principal. All employment, partnership, and “agent” relationships create an agency. The principal is generally responsible for the actions of the agent—at least within the scope of the agent’s authority. For example, the principal is responsible for the torts (civil liability resulting from the breach of a socially imposed duty, but generally not arising from a contract) of an agent doing the principal’s business. The agent has the obligation to act in good faith for the benefit of the principal and to abide by the instructions of the principal.
Corporate structures
There are a variety of corporate organizational structures; the basic types are corporations, partnerships, and unincorporated associations. These generally are available to nonprofit and for-profit organizations. As a general matter, corporations limit the owners’ personal liability; partnerships have tax advantages. A number of laws now allow the creation of entities that have both liability and tax advantages (subchapter S corporations, limited liability companies, and limited liability partnerships).
Other areas of business law
Employment law, which now affects almost every aspect of hiring, dismissal, payment, and fringe benefits, is not a single law but a series of state and federal statutes, regulations, and court decisions.8
Competition is regulated through a number of antitrust laws as well as fair business practices. These affect the ability of health care entities to merge, fix prices, and split markets.9
There are literally hundreds of other laws that affect the way health care entities can operate. Conducting a careful compliance review is of considerable importance.10
Read about the dos and don’ts of preventive law.
Dos and don’ts of preventive law
The business of medicine is subject to many laws and keeping track of all of these is generally beyond the expertise of the ObGyn. Here are a few practical suggestions for thriving in this legal milieu.
Understanding the law
DO establish an ongoing relationship with an attorney you can trust who is knowledgeable in health law. Consult with this attorney not only on an as-needed basis but also for an “annual checkup” of legal issues affecting your practice.
DON’T guess what the law is. Laws vary from state to state and change frequently. Taking curbstone advice or suggestions from a podcast is a good way to develop problems.
Error reduction
DO take risk management seriously. Implement plans to improve patient safety and reduce errors.11
DON’T ignore angry or hostile patients. Their hostility may be directed at you—an undesirable state. The same goes for disgruntled (or former) employees, who may become whistleblowers.
Insurance
DO review your insurance coverage annually, preferably with an expert or your attorney. Insurance policies and your insurance needs change frequently.
DON’T assume you have all the insurance you need or that insurance will cover all legal claims arising from your practice. Intentional torts, some antitrust claims, licensure discipline, and civil fines, for example, may not be covered.
Informed consent and ethics
DO use the informed consent process as a means of improving communication between you and your patients to address their concerns and discuss expectations. Autonomy is a basic ethical value of medicine and informed consent helps to achieve that goal.
DON’T ignore ethics. Ethical obligations are not just essential to maintaining a license, hospital privileges, and professional standing.12 They also help guide you toward good practice that avoids liability.
Related articles:
Informed consent: The more you know, the more you and your patient are protected
Compliance, disputes, and arbitration
DO engage in continuing compliance review. That includes understanding the contracts and professional arrangements in which you practice and all of the requirements of third-party payers (especially government entities). There are a wide range of other compliance obligations that require ongoing attention.
DON’T sign arbitration agreements without understanding exactly what you are agreeing to. There are advantages to arbitration,13 but there are disadvantages, too.14 The courts generally enforce arbitration agreements, even ones that are unfair or one-sided.15
The law need not be a mystery or the enemy. Preventive law, like preventive medicine, can make all the difference.16
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Carpentieri AM, Lumalcuri JJ, Shaw J, Joseph GF Jr. Overview of the 2015 American Congress of Obstetricians and Gynecologists’ Survey on Professional Liability. https://www.acog.org/-/media/Departments/Professional-Liability/2015PLSurveyNationalSummary11315.pdf?dmc=1&ts=20171003T150028497. Published November 3, 2015. Accessed October 3, 2017.
- American College of Obstetrics and Gynecology Committee on Professional Liability. ACOG Opinion No. 551: Coping with the stress of professional liability litigation. Obstet Gynecol. 2013;121(1):220–222.
- Teitlebaum JB, Wilensky SE. Essential of Health Policy and Law. 2nd ed. Burlington, MA: Jones & Bartlett Learning; 2012:31–43, 127–134.
- Fabrikant R, Kalb PE, Bucy PH, Hopson MD. Health Care Fraud: Enforcement and Compliance. Newark, NJ: Law Journal Press; 2017;4:44–140.
- Health Information Privacy. Department of Health and Human Services. https://www.hhs.gov/hipaa. Updated 2017. Accessed October 3, 2017.
- Kropf S. Healthcare Fraud 101: The False Claims Act. ObGyn.Net. http://www.obgyn.net/blog/healthcare-fraud-101-false-claims-act. Published March 10, 2017. Accessed October 3, 2017.
- Smith SR, Sanfilippo JS. Applied Business Law. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:91–126.
- Todd MK. The Physician Employment Contract Handbook: A Guide to Structuring Equitable Arrangements. 2nd ed. New York, NY: Productivity Press; 2011:67–77, 93–118.
- Federal Trade Commission. Competition in the Health Care Marketplace. https://www.ftc.gov/tips-advice/competition-guidance/industry-guidance/health-care. Updated 2017. Accessed October 3, 2017.
- Shwayder JM. What is new in medical-legal issues in obstetrics and gynecology?: Best articles from the past 2 years. Obstet Gynecol. 2016;128(6):1441–1442.
- Sanfilippo JS, Smith SR. Risk Management. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:277–298.
- Smith SR, Sanfilippo JS. Ethics and the Business of the Healthcare Professional. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:71–89.
- Knag PE, Kagan DJ. Why arbitration is the preferred dispute resolution vehicle for most integrated delivery system disputes. Dispute Resolution J. 2016;71(3):127–137.
- Larson DA, Dahl D. Medical malpractice arbitration: Not business as usual. Yearbook Arbitration Mediation. 2016;8:69–92.
- Trantina TL. What law applies to an agreement to arbitrate? American Bar Association. Dispute Resolution Magazine. Fall 2015:29–31.
- Curran M. Preventative law: Interdisciplinary from medical-legal partnership. NYU Rev Law Social Change. 2014;38(4):595–606.
- Carpentieri AM, Lumalcuri JJ, Shaw J, Joseph GF Jr. Overview of the 2015 American Congress of Obstetricians and Gynecologists’ Survey on Professional Liability. https://www.acog.org/-/media/Departments/Professional-Liability/2015PLSurveyNationalSummary11315.pdf?dmc=1&ts=20171003T150028497. Published November 3, 2015. Accessed October 3, 2017.
- American College of Obstetrics and Gynecology Committee on Professional Liability. ACOG Opinion No. 551: Coping with the stress of professional liability litigation. Obstet Gynecol. 2013;121(1):220–222.
- Teitlebaum JB, Wilensky SE. Essential of Health Policy and Law. 2nd ed. Burlington, MA: Jones & Bartlett Learning; 2012:31–43, 127–134.
- Fabrikant R, Kalb PE, Bucy PH, Hopson MD. Health Care Fraud: Enforcement and Compliance. Newark, NJ: Law Journal Press; 2017;4:44–140.
- Health Information Privacy. Department of Health and Human Services. https://www.hhs.gov/hipaa. Updated 2017. Accessed October 3, 2017.
- Kropf S. Healthcare Fraud 101: The False Claims Act. ObGyn.Net. http://www.obgyn.net/blog/healthcare-fraud-101-false-claims-act. Published March 10, 2017. Accessed October 3, 2017.
- Smith SR, Sanfilippo JS. Applied Business Law. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:91–126.
- Todd MK. The Physician Employment Contract Handbook: A Guide to Structuring Equitable Arrangements. 2nd ed. New York, NY: Productivity Press; 2011:67–77, 93–118.
- Federal Trade Commission. Competition in the Health Care Marketplace. https://www.ftc.gov/tips-advice/competition-guidance/industry-guidance/health-care. Updated 2017. Accessed October 3, 2017.
- Shwayder JM. What is new in medical-legal issues in obstetrics and gynecology?: Best articles from the past 2 years. Obstet Gynecol. 2016;128(6):1441–1442.
- Sanfilippo JS, Smith SR. Risk Management. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:277–298.
- Smith SR, Sanfilippo JS. Ethics and the Business of the Healthcare Professional. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:71–89.
- Knag PE, Kagan DJ. Why arbitration is the preferred dispute resolution vehicle for most integrated delivery system disputes. Dispute Resolution J. 2016;71(3):127–137.
- Larson DA, Dahl D. Medical malpractice arbitration: Not business as usual. Yearbook Arbitration Mediation. 2016;8:69–92.
- Trantina TL. What law applies to an agreement to arbitrate? American Bar Association. Dispute Resolution Magazine. Fall 2015:29–31.
- Curran M. Preventative law: Interdisciplinary from medical-legal partnership. NYU Rev Law Social Change. 2014;38(4):595–606.
In-hospital outcomes are better for vaccinated H1N1 patients
TORONTO – Patients who received an influenza vaccination but still required hospitalization for H1N1 influenza had better outcomes, compared with unvaccinated patients, according to findings from a retrospective study.
In the hospital, vaccinated patients had significantly lower rates of acute kidney injury (6% vs. 35%; P = .038) and were more likely to be satisfactorily managed with noninvasive mechanical ventilation (41% vs. 6%; P = .004).
Dr. Chandak and her colleagues studied 72 cases of seasonal influenza requiring hospitalization from September 2015 to April 2016 at Berkshire Medical Center, a 300-bed teaching hospital in western Massachusetts. Based on rapid polymerase chain reaction testing, 51 of these patients were positive for H1N1, of which 38 had received a seasonal flu vaccine.
H1N1 patients who had received vaccination were significantly older (70.4 years vs. 59.6 years; P = .016) and were more often smokers (76% vs. 38%; P = .017), compared with patients who were unvaccinated.
The finding that the unvaccinated patients were younger and still had poorer outcomes, “emphasizes the need for widespread vaccination,” Dr. Chandak said.
There were several parameters that trended in favor of vaccination, but did not reach statistical significance due to the relatively small sample size, Dr. Chandak said. These included a trend towards more ICU admission in the unvaccinated, compared with vaccinated patients (21% and 12%, respectively; P = .699), a longer ICU stay (1.7 days and 0.2 days; P = .144), more multiorgan dysfunction syndrome (12% and 6%; P = .654), and more acute respiratory distress syndrome (6% and 0%; P = .547). Vasopressors were needed in a similar proportion of patients (12% of both groups).
During the 2009-2010 flu season, H1N1 was the cause of about 61 million cases of influenza in the United States, 274,000 hospitalizations, and 12,470 deaths, Dr. Chandak reported.
Since the 2010-2011 influenza season, the trivalent influenza vaccine has included antigen from the 2009 pandemic H1N1 influenza A virus. This has prevented between 700,000 and 1.5 million cases of H1N1, up to 10,000 hospitalizations, and as many as 500 deaths, according to surveillance data (Emerg Infect Dis. 2013;19[3]:439-48).
The viral subtype made a strong reappearance in the 2015-2016 flu season when it was again the predominant viral subtype of the season, according to the CDC. Most studies have looked at the effectiveness of the vaccine, but have not studied critical care outcomes in vaccinated versus unvaccinated patients, Dr. Chandak noted.
Dr. Chandak reported having no financial disclosures.
Daniel Ouellette, MD, FCCP, comments: “I never take the flu vaccine,” my patient stated, following my suggestion that she be inoculated. “It makes me sick.”
I reflected on the cases of influenza patients that I took care of the previous year in the ICU: the 50-year-old man with no comorbidities who died in respiratory failure; the 32-year-old pregnant woman who survived a 3-month hospitalization during which she was treated with ECMO and suffered irreversible kidney failure. “I take it every year,” I told her.
While the influenza vaccine may not prevent all cases of influenza, those who develop influenza may have an attenuated illness. Data from Chandak and colleagues affirm improved outcomes in patients who receive the vaccine and still develop influenza. 
Daniel Ouellette, MD, FCCP, comments: “I never take the flu vaccine,” my patient stated, following my suggestion that she be inoculated. “It makes me sick.”
I reflected on the cases of influenza patients that I took care of the previous year in the ICU: the 50-year-old man with no comorbidities who died in respiratory failure; the 32-year-old pregnant woman who survived a 3-month hospitalization during which she was treated with ECMO and suffered irreversible kidney failure. “I take it every year,” I told her.
While the influenza vaccine may not prevent all cases of influenza, those who develop influenza may have an attenuated illness. Data from Chandak and colleagues affirm improved outcomes in patients who receive the vaccine and still develop influenza.
Daniel Ouellette, MD, FCCP, comments: “I never take the flu vaccine,” my patient stated, following my suggestion that she be inoculated. “It makes me sick.”
I reflected on the cases of influenza patients that I took care of the previous year in the ICU: the 50-year-old man with no comorbidities who died in respiratory failure; the 32-year-old pregnant woman who survived a 3-month hospitalization during which she was treated with ECMO and suffered irreversible kidney failure. “I take it every year,” I told her.
While the influenza vaccine may not prevent all cases of influenza, those who develop influenza may have an attenuated illness. Data from Chandak and colleagues affirm improved outcomes in patients who receive the vaccine and still develop influenza.
TORONTO – Patients who received an influenza vaccination but still required hospitalization for H1N1 influenza had better outcomes, compared with unvaccinated patients, according to findings from a retrospective study.
In the hospital, vaccinated patients had significantly lower rates of acute kidney injury (6% vs. 35%; P = .038) and were more likely to be satisfactorily managed with noninvasive mechanical ventilation (41% vs. 6%; P = .004).
Dr. Chandak and her colleagues studied 72 cases of seasonal influenza requiring hospitalization from September 2015 to April 2016 at Berkshire Medical Center, a 300-bed teaching hospital in western Massachusetts. Based on rapid polymerase chain reaction testing, 51 of these patients were positive for H1N1, of which 38 had received a seasonal flu vaccine.
H1N1 patients who had received vaccination were significantly older (70.4 years vs. 59.6 years; P = .016) and were more often smokers (76% vs. 38%; P = .017), compared with patients who were unvaccinated.
The finding that the unvaccinated patients were younger and still had poorer outcomes, “emphasizes the need for widespread vaccination,” Dr. Chandak said.
There were several parameters that trended in favor of vaccination, but did not reach statistical significance due to the relatively small sample size, Dr. Chandak said. These included a trend towards more ICU admission in the unvaccinated, compared with vaccinated patients (21% and 12%, respectively; P = .699), a longer ICU stay (1.7 days and 0.2 days; P = .144), more multiorgan dysfunction syndrome (12% and 6%; P = .654), and more acute respiratory distress syndrome (6% and 0%; P = .547). Vasopressors were needed in a similar proportion of patients (12% of both groups).
During the 2009-2010 flu season, H1N1 was the cause of about 61 million cases of influenza in the United States, 274,000 hospitalizations, and 12,470 deaths, Dr. Chandak reported.
Since the 2010-2011 influenza season, the trivalent influenza vaccine has included antigen from the 2009 pandemic H1N1 influenza A virus. This has prevented between 700,000 and 1.5 million cases of H1N1, up to 10,000 hospitalizations, and as many as 500 deaths, according to surveillance data (Emerg Infect Dis. 2013;19[3]:439-48).
The viral subtype made a strong reappearance in the 2015-2016 flu season when it was again the predominant viral subtype of the season, according to the CDC. Most studies have looked at the effectiveness of the vaccine, but have not studied critical care outcomes in vaccinated versus unvaccinated patients, Dr. Chandak noted.
Dr. Chandak reported having no financial disclosures.
TORONTO – Patients who received an influenza vaccination but still required hospitalization for H1N1 influenza had better outcomes, compared with unvaccinated patients, according to findings from a retrospective study.
In the hospital, vaccinated patients had significantly lower rates of acute kidney injury (6% vs. 35%; P = .038) and were more likely to be satisfactorily managed with noninvasive mechanical ventilation (41% vs. 6%; P = .004).
Dr. Chandak and her colleagues studied 72 cases of seasonal influenza requiring hospitalization from September 2015 to April 2016 at Berkshire Medical Center, a 300-bed teaching hospital in western Massachusetts. Based on rapid polymerase chain reaction testing, 51 of these patients were positive for H1N1, of which 38 had received a seasonal flu vaccine.
H1N1 patients who had received vaccination were significantly older (70.4 years vs. 59.6 years; P = .016) and were more often smokers (76% vs. 38%; P = .017), compared with patients who were unvaccinated.
The finding that the unvaccinated patients were younger and still had poorer outcomes, “emphasizes the need for widespread vaccination,” Dr. Chandak said.
There were several parameters that trended in favor of vaccination, but did not reach statistical significance due to the relatively small sample size, Dr. Chandak said. These included a trend towards more ICU admission in the unvaccinated, compared with vaccinated patients (21% and 12%, respectively; P = .699), a longer ICU stay (1.7 days and 0.2 days; P = .144), more multiorgan dysfunction syndrome (12% and 6%; P = .654), and more acute respiratory distress syndrome (6% and 0%; P = .547). Vasopressors were needed in a similar proportion of patients (12% of both groups).
During the 2009-2010 flu season, H1N1 was the cause of about 61 million cases of influenza in the United States, 274,000 hospitalizations, and 12,470 deaths, Dr. Chandak reported.
Since the 2010-2011 influenza season, the trivalent influenza vaccine has included antigen from the 2009 pandemic H1N1 influenza A virus. This has prevented between 700,000 and 1.5 million cases of H1N1, up to 10,000 hospitalizations, and as many as 500 deaths, according to surveillance data (Emerg Infect Dis. 2013;19[3]:439-48).
The viral subtype made a strong reappearance in the 2015-2016 flu season when it was again the predominant viral subtype of the season, according to the CDC. Most studies have looked at the effectiveness of the vaccine, but have not studied critical care outcomes in vaccinated versus unvaccinated patients, Dr. Chandak noted.
Dr. Chandak reported having no financial disclosures.
AT CHEST 2017
Key clinical point:
Major finding: Unvaccinated patients had a significantly higher risk of acute kidney injury (35% vs. 6%; P = .038) and were less likely to be managed with noninvasive mechanical ventilation (6% vs. 41%; P = .004).
Data source: Retrospective analysis including 72 reported influenza cases, 51 (71%) testing positive for H1N1.
Disclosures: Dr. Chandak reported having no financial disclosures.
Did long-term follow-up of WHI participants reveal any mortality increase among women who received HT?
EXPERT COMMENTARY
A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.1 Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.
Related article:
2017 Update on menopause
Details of the study
A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.
All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).
Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).
Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).
With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).
Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?
Study strengths and weaknesses
The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.
The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.
Given the complex impact of HT, all-cause mortality represents an important summary outcome in assessing the safety of 5 to 7 years of HT use. This report's reassuring findings regarding the safety of HT support the guidance from The North American Menopause Society and the Endocrine Society, which endorse the use of HT for symptomatic recently menopausal women without contraindications.2,3
--ANDREW M. KAUNITZ, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310(13):1353-1368.
- The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728-753.
- Stuenkel CA, Davis SR, Gompel A, et al. Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(11):3975-4011.
EXPERT COMMENTARY
A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.1 Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.
Related article:
2017 Update on menopause
Details of the study
A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.
All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).
Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).
Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).
With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).
Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?
Study strengths and weaknesses
The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.
The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.
Given the complex impact of HT, all-cause mortality represents an important summary outcome in assessing the safety of 5 to 7 years of HT use. This report's reassuring findings regarding the safety of HT support the guidance from The North American Menopause Society and the Endocrine Society, which endorse the use of HT for symptomatic recently menopausal women without contraindications.2,3
--ANDREW M. KAUNITZ, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
EXPERT COMMENTARY
A 2013 report from the Women’s Health Initiative (WHI), the large National Institutes of Health–funded placebo-controlledrandomized trial of postmenopausal hormone therapy (HT) with oral estrogen (for women with hysterectomy) or estrogen-progestin (for women with an intact uterus), with 13 years of cumulative follow-up, documented the safety of systemic HT when initiated by women younger than 60 years of age or within 10 years of menopause onset.1 Now, with 18 years of cumulative follow-up data available (intervention and extended postintervention phases), the WHI investigators present all-cause and cause-specific mortality outcomes from the 2 HT trials.
Related article:
2017 Update on menopause
Details of the study
A total of 27,347 WHI participants (baseline mean age, 63.4 years; 80.6% white) used oral estrogen-progestin therapy (EPT) or placebo for a median of 5.6 years (n = 16,608) or estrogen-only therapy (ET) or placebo for a median of 7.2 years (n = 10,739). Each hazard ratio (HR) reported below refers to 18-year cumulative follow-up.
All-cause mortality. In the overall pooled cohort (EPT and ET groups), all-cause mortality was similar, with a rate of 27.1% in the HT group and 27.6% in the placebo group (HR, 0.99; 95% confidence interval [CI], 0.94–1.03). The mortality end points included deaths from all causes; cardiovascular disease (coronary heart disease, stroke, and other cardiovascular diseases); cancer (breast, colorectal, and other cancers); and other (Alzheimer disease, other dementia, chronic obstructive pulmonary disease, injuries and accidents, and other).
Stratifying by baseline participant age (comparing women aged 50–59 years with those aged 70–79 years), the HR for all-cause mortality in the pooled cohort during the intervention phase was 0.61 (95% CI, 0.43–0.87), and during the cumulative 18-year follow-up, the HR was 0.87 (95% CI, 0.76–1.00).
Cause-specific mortality. Neither cardiovascular disease mortality nor total cancer mortality was significantly impacted by HT use. In the pooled cohort, cardiovascular disease mortality was 8.9% in the HT group and 9.0% in the placebo group (HR, 1.00; 95% CI, 0.92–1.08), with no differences between the EPT and the ET trials. Cancer mortality rates in the pooled cohort also were similar, with 8.2% in the HT group and 8.0% in the placebo group (HR, 1.03; 95% CI, 0.95–1.12).
With respect to breast cancer mortality, the impact of HT diverged for EPT and ET. For the EPT group, the HR for breast cancer mortality was 1.44 (95% CI, 0.97–2.15; P = .07), while for the ET group the HR was 0.55 (95% CI, 0.33–0.92; P = .02).
Related articles:
Does the discontinuation of menopausal hormone therapy affect a woman’s cardiovascular risk?
Study strengths and weaknesses
The WHI represents the largest randomized placebo-controlled trials of HT. The current WHI trials report provides new, cumulative 18-year follow-up data on all-cause and cause-specific mortality in women treated with HT or placebo.
The authors noted, however, that the use of only one HT dose, formulation, and route of administration in each trial may limit the generalizability of the study results to other HT preparations. For example, the WHI did not examine the transdermal route of estrogen administration. Likewise, the WHI did not examine use of progestational agents other than medroxyprogesterone acetate. In addition, while almost all cohort deaths were captured through the National Death Index for the data analyses, specificity of cause of death may vary across outcomes. Further, since multiple outcomes and subgroups were examined, clinicians should interpret cause-specific mortality rates with caution.
Given the complex impact of HT, all-cause mortality represents an important summary outcome in assessing the safety of 5 to 7 years of HT use. This report's reassuring findings regarding the safety of HT support the guidance from The North American Menopause Society and the Endocrine Society, which endorse the use of HT for symptomatic recently menopausal women without contraindications.2,3
--ANDREW M. KAUNITZ, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310(13):1353-1368.
- The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728-753.
- Stuenkel CA, Davis SR, Gompel A, et al. Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(11):3975-4011.
- Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013;310(13):1353-1368.
- The 2017 hormone therapy position statement of The North American Menopause Society. Menopause. 2017;24(7):728-753.
- Stuenkel CA, Davis SR, Gompel A, et al. Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(11):3975-4011.
Transient Epileptic Amnesia Is Not Associated With Elevated Risk of Alzheimer’s Disease
LONDON—Transient epileptic amnesia (TEA) does not appear to increase the risk of Alzheimer’s disease, according to a study presented at the 2017 Alzheimer’s Association International Conference. Persistent memory problems are common in patients with TEA, but the prevalence of dementia in these patients may not exceed that in the general population, the researchers noted.
TEA is a type of adult-onset temporal lobe epilepsy characterized by recurring amnestic seizures. Interictal memory deficits, such as autobiographic amnesia and accelerated long-term forgetting, are common. Short-term follow-up after initiating anticonvulsant medication suggests good seizure control and stable cognition. Recent case reports, however, have raised concerns that TEA may be a prodrome of Alzheimer’s disease.
Investigating Clinical and Cognitive Outcomes
To evaluate the basis for these concerns, Sharon A. Savage, PhD, Lecturer in Aging and Dementia at the University of Exeter Medical School in the United Kingdom, and colleagues investigated clinical and cognitive outcomes of patients with TEA over 10 to 20 years. They also assessed evidence of increased risk of Alzheimer’s disease. 
The researchers studied two cohorts of patients with TEA. The first cohort included 10 patients followed up at 10 years and 20 years. The second cohort included 42 patients followed up at 10 years. At baseline, both cohorts were compared with age- and IQ-matched healthy controls. Researchers also recorded Alzheimer’s disease diagnoses among participants with TEA and compared the prevalence of Alzheimer’s disease in the study populations with published prevalence rates.
In a subset of patients, Dr. Savage and colleagues assessed cognitive ability using the National Adult Reading Test or the Wechsler Abbreviated Scale of Intelligence. They assessed objective memory using the Logical Memory story 1, Rey Complex Figure, and the Recognition Memory Test. Additional testing examined naming, verbal fluency, and problem solving.
Fifty patients completed neuropsychologic review (mean age at baseline, 66). At last
Controls Performed Similarly to TEA Cohorts
At 20 years, no cases of Alzheimer’s disease were reported in Cohort 1. One participant in that group developed vascular dementia, and four died. Four patients in Cohort 2 had Alzheimer’s disease at 10 years, and 15 patients died, including one patient with Alzheimer’s disease.
When TEA data were compared with data from healthy controls, general cognitive ability among patients with TEA was above average with no decline at 10 and 20 years. In addition, significant change from baseline was observed at 10 years for story recall, recognition memory, verbal fluency, and problem solving. Overall, approximately one-third of patients with TEA remained stable or improved on individual test scores at 10 years.
At 20 years, general cognitive ability remained above average for patients with TEA, compared with controls. Performance was not significantly reduced on more than one memory measure per participant.
Researchers concluded that memory problems may continue in TEA despite effective cessation of seizures. Some patients may remain stable over 10 to 20 years, and others may decline. Additional changes in executive function may also develop over time in some patients, the researchers added.
“The prognosis of TEA appears relatively benign,” said Dr. Savage and colleagues. Patients in both TEA cohorts performed similarly to healthy controls on the majority of tests. In addition, life expectancy did not appear to decrease, and seizures were generally well controlled.
—Erica Tricarico
LONDON—Transient epileptic amnesia (TEA) does not appear to increase the risk of Alzheimer’s disease, according to a study presented at the 2017 Alzheimer’s Association International Conference. Persistent memory problems are common in patients with TEA, but the prevalence of dementia in these patients may not exceed that in the general population, the researchers noted.
TEA is a type of adult-onset temporal lobe epilepsy characterized by recurring amnestic seizures. Interictal memory deficits, such as autobiographic amnesia and accelerated long-term forgetting, are common. Short-term follow-up after initiating anticonvulsant medication suggests good seizure control and stable cognition. Recent case reports, however, have raised concerns that TEA may be a prodrome of Alzheimer’s disease.
Investigating Clinical and Cognitive Outcomes
To evaluate the basis for these concerns, Sharon A. Savage, PhD, Lecturer in Aging and Dementia at the University of Exeter Medical School in the United Kingdom, and colleagues investigated clinical and cognitive outcomes of patients with TEA over 10 to 20 years. They also assessed evidence of increased risk of Alzheimer’s disease.
The researchers studied two cohorts of patients with TEA. The first cohort included 10 patients followed up at 10 years and 20 years. The second cohort included 42 patients followed up at 10 years. At baseline, both cohorts were compared with age- and IQ-matched healthy controls. Researchers also recorded Alzheimer’s disease diagnoses among participants with TEA and compared the prevalence of Alzheimer’s disease in the study populations with published prevalence rates.
In a subset of patients, Dr. Savage and colleagues assessed cognitive ability using the National Adult Reading Test or the Wechsler Abbreviated Scale of Intelligence. They assessed objective memory using the Logical Memory story 1, Rey Complex Figure, and the Recognition Memory Test. Additional testing examined naming, verbal fluency, and problem solving.
Fifty patients completed neuropsychologic review (mean age at baseline, 66). At last
Controls Performed Similarly to TEA Cohorts
At 20 years, no cases of Alzheimer’s disease were reported in Cohort 1. One participant in that group developed vascular dementia, and four died. Four patients in Cohort 2 had Alzheimer’s disease at 10 years, and 15 patients died, including one patient with Alzheimer’s disease.
When TEA data were compared with data from healthy controls, general cognitive ability among patients with TEA was above average with no decline at 10 and 20 years. In addition, significant change from baseline was observed at 10 years for story recall, recognition memory, verbal fluency, and problem solving. Overall, approximately one-third of patients with TEA remained stable or improved on individual test scores at 10 years.
At 20 years, general cognitive ability remained above average for patients with TEA, compared with controls. Performance was not significantly reduced on more than one memory measure per participant.
Researchers concluded that memory problems may continue in TEA despite effective cessation of seizures. Some patients may remain stable over 10 to 20 years, and others may decline. Additional changes in executive function may also develop over time in some patients, the researchers added.
“The prognosis of TEA appears relatively benign,” said Dr. Savage and colleagues. Patients in both TEA cohorts performed similarly to healthy controls on the majority of tests. In addition, life expectancy did not appear to decrease, and seizures were generally well controlled.
—Erica Tricarico
LONDON—Transient epileptic amnesia (TEA) does not appear to increase the risk of Alzheimer’s disease, according to a study presented at the 2017 Alzheimer’s Association International Conference. Persistent memory problems are common in patients with TEA, but the prevalence of dementia in these patients may not exceed that in the general population, the researchers noted.
TEA is a type of adult-onset temporal lobe epilepsy characterized by recurring amnestic seizures. Interictal memory deficits, such as autobiographic amnesia and accelerated long-term forgetting, are common. Short-term follow-up after initiating anticonvulsant medication suggests good seizure control and stable cognition. Recent case reports, however, have raised concerns that TEA may be a prodrome of Alzheimer’s disease.
Investigating Clinical and Cognitive Outcomes
To evaluate the basis for these concerns, Sharon A. Savage, PhD, Lecturer in Aging and Dementia at the University of Exeter Medical School in the United Kingdom, and colleagues investigated clinical and cognitive outcomes of patients with TEA over 10 to 20 years. They also assessed evidence of increased risk of Alzheimer’s disease.
The researchers studied two cohorts of patients with TEA. The first cohort included 10 patients followed up at 10 years and 20 years. The second cohort included 42 patients followed up at 10 years. At baseline, both cohorts were compared with age- and IQ-matched healthy controls. Researchers also recorded Alzheimer’s disease diagnoses among participants with TEA and compared the prevalence of Alzheimer’s disease in the study populations with published prevalence rates.
In a subset of patients, Dr. Savage and colleagues assessed cognitive ability using the National Adult Reading Test or the Wechsler Abbreviated Scale of Intelligence. They assessed objective memory using the Logical Memory story 1, Rey Complex Figure, and the Recognition Memory Test. Additional testing examined naming, verbal fluency, and problem solving.
Fifty patients completed neuropsychologic review (mean age at baseline, 66). At last
Controls Performed Similarly to TEA Cohorts
At 20 years, no cases of Alzheimer’s disease were reported in Cohort 1. One participant in that group developed vascular dementia, and four died. Four patients in Cohort 2 had Alzheimer’s disease at 10 years, and 15 patients died, including one patient with Alzheimer’s disease.
When TEA data were compared with data from healthy controls, general cognitive ability among patients with TEA was above average with no decline at 10 and 20 years. In addition, significant change from baseline was observed at 10 years for story recall, recognition memory, verbal fluency, and problem solving. Overall, approximately one-third of patients with TEA remained stable or improved on individual test scores at 10 years.
At 20 years, general cognitive ability remained above average for patients with TEA, compared with controls. Performance was not significantly reduced on more than one memory measure per participant.
Researchers concluded that memory problems may continue in TEA despite effective cessation of seizures. Some patients may remain stable over 10 to 20 years, and others may decline. Additional changes in executive function may also develop over time in some patients, the researchers added.
“The prognosis of TEA appears relatively benign,” said Dr. Savage and colleagues. Patients in both TEA cohorts performed similarly to healthy controls on the majority of tests. In addition, life expectancy did not appear to decrease, and seizures were generally well controlled.
—Erica Tricarico
VIDEO: High-volume endoscopists, centers produced better ERCP outcomes
Endoscopists who performed endoscopic retrograde cholangiopancreatography (ERCP) at high-volume centers had a 60% greater odds of procedure success compared with those at low-volume centers, according to the results of a systematic review and meta-analysis.
High-volume endoscopists also had a 30% lower odds of performing ERCP that led to adverse events such as pancreatitis, perforation, and bleeding, reported Rajesh N. Keswani, MD, MS, of Northwestern University, Chicago, and his associates. High-volume centers themselves also were associated with a significantly higher odds of successful ERCP (odds ratio, 2.0; 95% CI, 1.6 to 2.5), although they were not associated with a significantly lower risk of adverse events, the reviewers wrote. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.002).
Diagnostic ERCP has fallen sevenfold in the past 30 years while therapeutic use has increased 30-fold, the researchers noted. Therapeutic use spans several complex pancreaticobiliary conditions, including chronic pancreatitis, malignant jaundice, and complications of liver transplantation. This shift from diagnostic to therapeutic has naturally increased the complexity of ERCP, the need for expert endoscopy, and the potential risk of adverse events. “As health care continues to shift toward rewarding value rather than volume, it will be increasingly important to deliver care that is effective and efficient,” the reviewers wrote. “Thus, understanding factors associated with unsuccessful interventions, such as a failed ERCP, will be of critical importance to payers and patients (Clin Gastroenterol Hepatol. 2017 Jun 7;218:237-45).
Therefore, they searched MEDLINE, EMBASE, and the Cochrane register of controlled trials for prospective and retrospective studies published through January 2017. In all, the researchers identified 13 studies that stratified outcomes by volume per endoscopist or center. These studies comprised 59,437 procedures and patients. Definitions of low volume varied by study, ranging from less than 25 to less than 156 annual ERCPs per endoscopist and from less than 87 to less than 200 annual ERCPs per center. Endoscopists who achieved this threshold were significantly more likely to perform successful ERCPs than were low-volume endoscopists (OR, 1.6; 95% CI, 1.2 to 2.1), and were significantly less likely to have patients develop pancreatitis, perforation, or bleeding after ERCP (OR, 0.7; 95% CI, 0.5 to 0.8).
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
“Given these compelling findings, we propose that providers and payers consider consolidating ERCP to high-volume endoscopists and centers to improve ERCP outcomes and value,” the reviewers wrote. Minimum thresholds for endoscopists and centers to maintain ERCP skills and optimize outcomes have not been defined, they noted. Intuitively, there is no “critical volume threshold” at which “outcomes suddenly improve,” but the studies in this analysis used widely varying definitions of low volume, they added. It also remains unclear whether a low-volume endoscopist can achieve optimal outcomes at a high-volume center, or vice versa, they said. They recommended studies to better define procedure success and the appropriate use of ERCP in therapeutic settings.
One reviewer acknowledged support from the University of Colorado Department of Medicine Outstanding Early Career Faculty Program. The reviewers reported having no conflicts of interest.
With the increasing proportion of complex therapeutic ERCPs, the field is shifting toward performance of these procedures by those who have had advanced training and who make them the focus of their clinical practice. Consistent with this, the meta-analysis by Keswani et al. highlights benefits of higher-volume centers and endoscopists - improved ERCP success rate (at the provider and practice level) and reduced adverse events (provider level only). It is unclear, however, if higher-volume endoscopists received additional training that translated into better outcomes. Other variables, including case complexity and provider experience, could not be fully assessed in this study.
Overall, however, this large, well-performed meta-analysis adds to the growing chorus that endoscopists and endoscopic centers will have better results if the endoscopists are specially trained and routinely perform these procedures. Future studies are needed to more accurately define procedure success (significant variation in the meta-analysis) and assess other variables that affect outcomes for which volume may only be a proxy. In an era of reporting and demonstrating value in endoscopic care, quality metrics for ERCP performance may not be fully appreciated but eventually may become the driving force in consolidation of these procedures to particular centers or providers, regardless of volume.
Avinash Ketwaroo, MD, MSc, is assistant professor in the division of gastroenterology and hepatology at Baylor College of Medicine, Houston, and an associate editor of GI & Hepatology News. He has no relevant conflicts of interest.
With the increasing proportion of complex therapeutic ERCPs, the field is shifting toward performance of these procedures by those who have had advanced training and who make them the focus of their clinical practice. Consistent with this, the meta-analysis by Keswani et al. highlights benefits of higher-volume centers and endoscopists - improved ERCP success rate (at the provider and practice level) and reduced adverse events (provider level only). It is unclear, however, if higher-volume endoscopists received additional training that translated into better outcomes. Other variables, including case complexity and provider experience, could not be fully assessed in this study.
Overall, however, this large, well-performed meta-analysis adds to the growing chorus that endoscopists and endoscopic centers will have better results if the endoscopists are specially trained and routinely perform these procedures. Future studies are needed to more accurately define procedure success (significant variation in the meta-analysis) and assess other variables that affect outcomes for which volume may only be a proxy. In an era of reporting and demonstrating value in endoscopic care, quality metrics for ERCP performance may not be fully appreciated but eventually may become the driving force in consolidation of these procedures to particular centers or providers, regardless of volume.
Avinash Ketwaroo, MD, MSc, is assistant professor in the division of gastroenterology and hepatology at Baylor College of Medicine, Houston, and an associate editor of GI & Hepatology News. He has no relevant conflicts of interest.
With the increasing proportion of complex therapeutic ERCPs, the field is shifting toward performance of these procedures by those who have had advanced training and who make them the focus of their clinical practice. Consistent with this, the meta-analysis by Keswani et al. highlights benefits of higher-volume centers and endoscopists - improved ERCP success rate (at the provider and practice level) and reduced adverse events (provider level only). It is unclear, however, if higher-volume endoscopists received additional training that translated into better outcomes. Other variables, including case complexity and provider experience, could not be fully assessed in this study.
Overall, however, this large, well-performed meta-analysis adds to the growing chorus that endoscopists and endoscopic centers will have better results if the endoscopists are specially trained and routinely perform these procedures. Future studies are needed to more accurately define procedure success (significant variation in the meta-analysis) and assess other variables that affect outcomes for which volume may only be a proxy. In an era of reporting and demonstrating value in endoscopic care, quality metrics for ERCP performance may not be fully appreciated but eventually may become the driving force in consolidation of these procedures to particular centers or providers, regardless of volume.
Avinash Ketwaroo, MD, MSc, is assistant professor in the division of gastroenterology and hepatology at Baylor College of Medicine, Houston, and an associate editor of GI & Hepatology News. He has no relevant conflicts of interest.
Endoscopists who performed endoscopic retrograde cholangiopancreatography (ERCP) at high-volume centers had a 60% greater odds of procedure success compared with those at low-volume centers, according to the results of a systematic review and meta-analysis.
High-volume endoscopists also had a 30% lower odds of performing ERCP that led to adverse events such as pancreatitis, perforation, and bleeding, reported Rajesh N. Keswani, MD, MS, of Northwestern University, Chicago, and his associates. High-volume centers themselves also were associated with a significantly higher odds of successful ERCP (odds ratio, 2.0; 95% CI, 1.6 to 2.5), although they were not associated with a significantly lower risk of adverse events, the reviewers wrote. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.002).
Diagnostic ERCP has fallen sevenfold in the past 30 years while therapeutic use has increased 30-fold, the researchers noted. Therapeutic use spans several complex pancreaticobiliary conditions, including chronic pancreatitis, malignant jaundice, and complications of liver transplantation. This shift from diagnostic to therapeutic has naturally increased the complexity of ERCP, the need for expert endoscopy, and the potential risk of adverse events. “As health care continues to shift toward rewarding value rather than volume, it will be increasingly important to deliver care that is effective and efficient,” the reviewers wrote. “Thus, understanding factors associated with unsuccessful interventions, such as a failed ERCP, will be of critical importance to payers and patients (Clin Gastroenterol Hepatol. 2017 Jun 7;218:237-45).
Therefore, they searched MEDLINE, EMBASE, and the Cochrane register of controlled trials for prospective and retrospective studies published through January 2017. In all, the researchers identified 13 studies that stratified outcomes by volume per endoscopist or center. These studies comprised 59,437 procedures and patients. Definitions of low volume varied by study, ranging from less than 25 to less than 156 annual ERCPs per endoscopist and from less than 87 to less than 200 annual ERCPs per center. Endoscopists who achieved this threshold were significantly more likely to perform successful ERCPs than were low-volume endoscopists (OR, 1.6; 95% CI, 1.2 to 2.1), and were significantly less likely to have patients develop pancreatitis, perforation, or bleeding after ERCP (OR, 0.7; 95% CI, 0.5 to 0.8).
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
“Given these compelling findings, we propose that providers and payers consider consolidating ERCP to high-volume endoscopists and centers to improve ERCP outcomes and value,” the reviewers wrote. Minimum thresholds for endoscopists and centers to maintain ERCP skills and optimize outcomes have not been defined, they noted. Intuitively, there is no “critical volume threshold” at which “outcomes suddenly improve,” but the studies in this analysis used widely varying definitions of low volume, they added. It also remains unclear whether a low-volume endoscopist can achieve optimal outcomes at a high-volume center, or vice versa, they said. They recommended studies to better define procedure success and the appropriate use of ERCP in therapeutic settings.
One reviewer acknowledged support from the University of Colorado Department of Medicine Outstanding Early Career Faculty Program. The reviewers reported having no conflicts of interest.
Endoscopists who performed endoscopic retrograde cholangiopancreatography (ERCP) at high-volume centers had a 60% greater odds of procedure success compared with those at low-volume centers, according to the results of a systematic review and meta-analysis.
High-volume endoscopists also had a 30% lower odds of performing ERCP that led to adverse events such as pancreatitis, perforation, and bleeding, reported Rajesh N. Keswani, MD, MS, of Northwestern University, Chicago, and his associates. High-volume centers themselves also were associated with a significantly higher odds of successful ERCP (odds ratio, 2.0; 95% CI, 1.6 to 2.5), although they were not associated with a significantly lower risk of adverse events, the reviewers wrote. The study was published in the December issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.06.002).
Diagnostic ERCP has fallen sevenfold in the past 30 years while therapeutic use has increased 30-fold, the researchers noted. Therapeutic use spans several complex pancreaticobiliary conditions, including chronic pancreatitis, malignant jaundice, and complications of liver transplantation. This shift from diagnostic to therapeutic has naturally increased the complexity of ERCP, the need for expert endoscopy, and the potential risk of adverse events. “As health care continues to shift toward rewarding value rather than volume, it will be increasingly important to deliver care that is effective and efficient,” the reviewers wrote. “Thus, understanding factors associated with unsuccessful interventions, such as a failed ERCP, will be of critical importance to payers and patients (Clin Gastroenterol Hepatol. 2017 Jun 7;218:237-45).
Therefore, they searched MEDLINE, EMBASE, and the Cochrane register of controlled trials for prospective and retrospective studies published through January 2017. In all, the researchers identified 13 studies that stratified outcomes by volume per endoscopist or center. These studies comprised 59,437 procedures and patients. Definitions of low volume varied by study, ranging from less than 25 to less than 156 annual ERCPs per endoscopist and from less than 87 to less than 200 annual ERCPs per center. Endoscopists who achieved this threshold were significantly more likely to perform successful ERCPs than were low-volume endoscopists (OR, 1.6; 95% CI, 1.2 to 2.1), and were significantly less likely to have patients develop pancreatitis, perforation, or bleeding after ERCP (OR, 0.7; 95% CI, 0.5 to 0.8).
SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION
“Given these compelling findings, we propose that providers and payers consider consolidating ERCP to high-volume endoscopists and centers to improve ERCP outcomes and value,” the reviewers wrote. Minimum thresholds for endoscopists and centers to maintain ERCP skills and optimize outcomes have not been defined, they noted. Intuitively, there is no “critical volume threshold” at which “outcomes suddenly improve,” but the studies in this analysis used widely varying definitions of low volume, they added. It also remains unclear whether a low-volume endoscopist can achieve optimal outcomes at a high-volume center, or vice versa, they said. They recommended studies to better define procedure success and the appropriate use of ERCP in therapeutic settings.
One reviewer acknowledged support from the University of Colorado Department of Medicine Outstanding Early Career Faculty Program. The reviewers reported having no conflicts of interest.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: High endoscopic retrograde cholangiopancreatography (ERCP) volume predicted procedure success.
Major finding: High-volume endoscopists were significantly more likely to achieve success with ERCP than were low-volume endoscopists (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.1). High-volume centers also had greater odds of successful ERCP than did low-volume centers (OR, 2; 95% CI, 1.6 to 2.5).
Data source: A systematic review and meta-analysis of 13 studies comprising 59,437 procedures and patients.
Disclosures: One coinvestigator acknowledged support from the University of Colorado Department of Medicine Outstanding Early Career Faculty Program. The researchers reported having no conflicts of interest.
Meta-analysis confirms probiotics’ pediatric safety and efficacy
ORLANDO – Probiotics are safe and effective for treating functional abdominal pain in children, based on findings from a meta-analysis of 11 randomized studies with a total of 790 patients.
“We think there is pretty strong evidence” for the efficacy of probiotics, and “by any analysis you can throw at them probiotics are safe,” Gordon Morris, MD, said at the World Congress of Gastroenterology at ACG 2017. “The evidence is of moderate and high quality,” added Dr. Morris, a pediatric gastroenterologist at the University of Central Lancashire in Preston, England.
The most widely studied probiotic in the analysis was Lactobacillus reuteri, used in six of the studies with a total of 405 randomized patients. The next most commonly studied agent was Lactobacillus rhamnosus GG, the focus of four studies and tested in a total of 270 randomized patients. Both microbes showed statistically significant and clinically meaningful levels of pain reduction when compared with placebo in subgroup analyses, said Dr. Morris, who performed the meta-analysis as a Cochrane Review Groups systematic review.
“The pain score reductions we saw [with these two strains] could certainly have an impact. I think it matters clinically,” he explained. “Severity of pain is most important to patients.”
Both L. reuteri and L. rhamnosus GG have received “generally regarded as safe” designations from the Food and Drug Administration.
Based on these findings, “I don’t think we can justify, especially with these two main strains, any further basic efficacy studies,” Dr. Morris said. The primary focus for future clinical assessments of these probiotics should be long-term efficacy and safety and whether patients have rebound pain on withdrawal from probiotic use, he added.
The meta-analysis used studies that compared probiotics against placebo in children aged 4-18 years who received treatment for 4-16 weeks. The full analysis showed an average 0.57-unit reduction in pain scores across all 11 studies included, with an average 0.61-unit reduction using L. reuteri and an average 0.75-unit reduction using L. rhamnosus GG. All three between-group differences were statistically significant. Safety data came from eight of the included studies, and they collectively showed absolutely no safety difference between actively treated and control patients.
Dr. Morris noted that the mechanism by which probiotic bacilli relieve abdominal pain remains unclear, but suggested that both prokinetic and anti-inflammatory effects might be involved.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Probiotics are safe and effective for treating functional abdominal pain in children, based on findings from a meta-analysis of 11 randomized studies with a total of 790 patients.
“We think there is pretty strong evidence” for the efficacy of probiotics, and “by any analysis you can throw at them probiotics are safe,” Gordon Morris, MD, said at the World Congress of Gastroenterology at ACG 2017. “The evidence is of moderate and high quality,” added Dr. Morris, a pediatric gastroenterologist at the University of Central Lancashire in Preston, England.
The most widely studied probiotic in the analysis was Lactobacillus reuteri, used in six of the studies with a total of 405 randomized patients. The next most commonly studied agent was Lactobacillus rhamnosus GG, the focus of four studies and tested in a total of 270 randomized patients. Both microbes showed statistically significant and clinically meaningful levels of pain reduction when compared with placebo in subgroup analyses, said Dr. Morris, who performed the meta-analysis as a Cochrane Review Groups systematic review.
“The pain score reductions we saw [with these two strains] could certainly have an impact. I think it matters clinically,” he explained. “Severity of pain is most important to patients.”
Both L. reuteri and L. rhamnosus GG have received “generally regarded as safe” designations from the Food and Drug Administration.
Based on these findings, “I don’t think we can justify, especially with these two main strains, any further basic efficacy studies,” Dr. Morris said. The primary focus for future clinical assessments of these probiotics should be long-term efficacy and safety and whether patients have rebound pain on withdrawal from probiotic use, he added.
The meta-analysis used studies that compared probiotics against placebo in children aged 4-18 years who received treatment for 4-16 weeks. The full analysis showed an average 0.57-unit reduction in pain scores across all 11 studies included, with an average 0.61-unit reduction using L. reuteri and an average 0.75-unit reduction using L. rhamnosus GG. All three between-group differences were statistically significant. Safety data came from eight of the included studies, and they collectively showed absolutely no safety difference between actively treated and control patients.
Dr. Morris noted that the mechanism by which probiotic bacilli relieve abdominal pain remains unclear, but suggested that both prokinetic and anti-inflammatory effects might be involved.
[email protected]
On Twitter @mitchelzoler
ORLANDO – Probiotics are safe and effective for treating functional abdominal pain in children, based on findings from a meta-analysis of 11 randomized studies with a total of 790 patients.
“We think there is pretty strong evidence” for the efficacy of probiotics, and “by any analysis you can throw at them probiotics are safe,” Gordon Morris, MD, said at the World Congress of Gastroenterology at ACG 2017. “The evidence is of moderate and high quality,” added Dr. Morris, a pediatric gastroenterologist at the University of Central Lancashire in Preston, England.
The most widely studied probiotic in the analysis was Lactobacillus reuteri, used in six of the studies with a total of 405 randomized patients. The next most commonly studied agent was Lactobacillus rhamnosus GG, the focus of four studies and tested in a total of 270 randomized patients. Both microbes showed statistically significant and clinically meaningful levels of pain reduction when compared with placebo in subgroup analyses, said Dr. Morris, who performed the meta-analysis as a Cochrane Review Groups systematic review.
“The pain score reductions we saw [with these two strains] could certainly have an impact. I think it matters clinically,” he explained. “Severity of pain is most important to patients.”
Both L. reuteri and L. rhamnosus GG have received “generally regarded as safe” designations from the Food and Drug Administration.
Based on these findings, “I don’t think we can justify, especially with these two main strains, any further basic efficacy studies,” Dr. Morris said. The primary focus for future clinical assessments of these probiotics should be long-term efficacy and safety and whether patients have rebound pain on withdrawal from probiotic use, he added.
The meta-analysis used studies that compared probiotics against placebo in children aged 4-18 years who received treatment for 4-16 weeks. The full analysis showed an average 0.57-unit reduction in pain scores across all 11 studies included, with an average 0.61-unit reduction using L. reuteri and an average 0.75-unit reduction using L. rhamnosus GG. All three between-group differences were statistically significant. Safety data came from eight of the included studies, and they collectively showed absolutely no safety difference between actively treated and control patients.
Dr. Morris noted that the mechanism by which probiotic bacilli relieve abdominal pain remains unclear, but suggested that both prokinetic and anti-inflammatory effects might be involved.
[email protected]
On Twitter @mitchelzoler
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Probiotic treatment led to an average 0.57-unit reduction in pain intensity compared with placebo controls.
Data source: A Cochrane Group meta-analysis of 11 studies with 790 patients.
Disclosures: Dr. Morris had no disclosures.
Product Update: Natera’s Panorama NIPT; Solosec from Symbiomix Therapeutics
NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS
Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.
FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/
NEW DRUG FOR TREATING BACTERIAL VAGINOSIS
Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.
FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS
Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.
FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/
NEW DRUG FOR TREATING BACTERIAL VAGINOSIS
Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.
FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS
Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.
FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/
NEW DRUG FOR TREATING BACTERIAL VAGINOSIS
Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.
FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
VIDEO: Back off on screening colonoscopy after nonadvanced adenomas
ORLANDO – Evidence supports “backing off” from screening colonoscopies every 5 years for patients who had one or two nonadvanced adenomas removed during a prior colonoscopy, Thomas F. Imperiale, MD, AGAF, said at the World Congress of Gastroenterology at ACG 2017.
He reported findings from more than 66,000 U.S. veterans followed at any one of 13 Veterans Affairs medical centers for an average of more than 7 years. The 10,220 patients who underwent a second screening colonoscopy after an index colonoscopy that led to removal of one or two nonadvanced adenomas had 0.16% colorectal cancer mortality, compared with 0.13% among 8,718 patients with a similar history who did not receive follow-up colonoscopy. The rate of colorectal cancer death was 0.12% among 47,629 control veterans who had no adenomas removed during their index colonoscopy.
In current U.S. practice, many gastroenterologists perform follow-up colonoscopy about 5 years after removing one or two nonadvanced adenomas during a screening colonoscopy, Dr. Imperiale said during a video interview. Deferring follow-up colonoscopy in the absence of any clinical indication seems advisable, he said, especially for older patients with two or more comorbidities who had a high-quality index colonoscopy with good preparation and good colonic visibility.
“We just can’t do colonoscopy for surveillance on this subgroup continuously; it doesn’t make sense,” he said.
No randomized trial results have documented the need for stepped up colonoscopies in patients with a history of one or two nonadvanced adenomas, and these new observational findings are consistent with prior observational reports.
“These data need to be integrated with common sense,” he said. An extended interval before repeat surveillance seems particularly appropriate for patients with a higher risk for adverse effects from the colonoscopy preparation and for patients more likely to die from a cause other than colorectal cancer.
Backing off on repeat colonoscopy “minimizes the harm from surveillance. As patients get older they don’t tolerate the prep as well. It grows more onerous, and the returns diminish,” Dr. Imperiale said.
The patients included in the review had their index colonoscopy performed during 2002-2009, when they averaged about 61 years old, and about 95% were men. Their average Charlson comorbidity index was about 1.3. The incidence of colorectal cancer during follow-up after the index colonoscopy was 0.18% in patients with one or two nonadvanced adenomas in their index examination and no follow-up colonoscopy, 0.71% in those with nonadvanced adenomas who had one or more subsequent colonoscopies, and 0.31% in the people with no adenomas removed during the index procedure.
The rates of all-cause death during follow-up of the three subgroups were notably different: 34% in those with nonadvanced adenomas and no repeat colonoscopy, 13% in patients with nonadvanced adenomas and repeat colonoscopy, and 21% in those without nonadvanced adenomas. Dr. Imperiale discounted the significance of comparing rates of all-cause mortality, stressing that the most relevant primary endpoint is colorectal cancer mortality.
Dr. Imperiale reported having no disclosures.
[email protected]
On Twitter @mitchelzoler
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Evidence supports “backing off” from screening colonoscopies every 5 years for patients who had one or two nonadvanced adenomas removed during a prior colonoscopy, Thomas F. Imperiale, MD, AGAF, said at the World Congress of Gastroenterology at ACG 2017.
He reported findings from more than 66,000 U.S. veterans followed at any one of 13 Veterans Affairs medical centers for an average of more than 7 years. The 10,220 patients who underwent a second screening colonoscopy after an index colonoscopy that led to removal of one or two nonadvanced adenomas had 0.16% colorectal cancer mortality, compared with 0.13% among 8,718 patients with a similar history who did not receive follow-up colonoscopy. The rate of colorectal cancer death was 0.12% among 47,629 control veterans who had no adenomas removed during their index colonoscopy.
In current U.S. practice, many gastroenterologists perform follow-up colonoscopy about 5 years after removing one or two nonadvanced adenomas during a screening colonoscopy, Dr. Imperiale said during a video interview. Deferring follow-up colonoscopy in the absence of any clinical indication seems advisable, he said, especially for older patients with two or more comorbidities who had a high-quality index colonoscopy with good preparation and good colonic visibility.
“We just can’t do colonoscopy for surveillance on this subgroup continuously; it doesn’t make sense,” he said.
No randomized trial results have documented the need for stepped up colonoscopies in patients with a history of one or two nonadvanced adenomas, and these new observational findings are consistent with prior observational reports.
“These data need to be integrated with common sense,” he said. An extended interval before repeat surveillance seems particularly appropriate for patients with a higher risk for adverse effects from the colonoscopy preparation and for patients more likely to die from a cause other than colorectal cancer.
Backing off on repeat colonoscopy “minimizes the harm from surveillance. As patients get older they don’t tolerate the prep as well. It grows more onerous, and the returns diminish,” Dr. Imperiale said.
The patients included in the review had their index colonoscopy performed during 2002-2009, when they averaged about 61 years old, and about 95% were men. Their average Charlson comorbidity index was about 1.3. The incidence of colorectal cancer during follow-up after the index colonoscopy was 0.18% in patients with one or two nonadvanced adenomas in their index examination and no follow-up colonoscopy, 0.71% in those with nonadvanced adenomas who had one or more subsequent colonoscopies, and 0.31% in the people with no adenomas removed during the index procedure.
The rates of all-cause death during follow-up of the three subgroups were notably different: 34% in those with nonadvanced adenomas and no repeat colonoscopy, 13% in patients with nonadvanced adenomas and repeat colonoscopy, and 21% in those without nonadvanced adenomas. Dr. Imperiale discounted the significance of comparing rates of all-cause mortality, stressing that the most relevant primary endpoint is colorectal cancer mortality.
Dr. Imperiale reported having no disclosures.
[email protected]
On Twitter @mitchelzoler
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ORLANDO – Evidence supports “backing off” from screening colonoscopies every 5 years for patients who had one or two nonadvanced adenomas removed during a prior colonoscopy, Thomas F. Imperiale, MD, AGAF, said at the World Congress of Gastroenterology at ACG 2017.
He reported findings from more than 66,000 U.S. veterans followed at any one of 13 Veterans Affairs medical centers for an average of more than 7 years. The 10,220 patients who underwent a second screening colonoscopy after an index colonoscopy that led to removal of one or two nonadvanced adenomas had 0.16% colorectal cancer mortality, compared with 0.13% among 8,718 patients with a similar history who did not receive follow-up colonoscopy. The rate of colorectal cancer death was 0.12% among 47,629 control veterans who had no adenomas removed during their index colonoscopy.
In current U.S. practice, many gastroenterologists perform follow-up colonoscopy about 5 years after removing one or two nonadvanced adenomas during a screening colonoscopy, Dr. Imperiale said during a video interview. Deferring follow-up colonoscopy in the absence of any clinical indication seems advisable, he said, especially for older patients with two or more comorbidities who had a high-quality index colonoscopy with good preparation and good colonic visibility.
“We just can’t do colonoscopy for surveillance on this subgroup continuously; it doesn’t make sense,” he said.
No randomized trial results have documented the need for stepped up colonoscopies in patients with a history of one or two nonadvanced adenomas, and these new observational findings are consistent with prior observational reports.
“These data need to be integrated with common sense,” he said. An extended interval before repeat surveillance seems particularly appropriate for patients with a higher risk for adverse effects from the colonoscopy preparation and for patients more likely to die from a cause other than colorectal cancer.
Backing off on repeat colonoscopy “minimizes the harm from surveillance. As patients get older they don’t tolerate the prep as well. It grows more onerous, and the returns diminish,” Dr. Imperiale said.
The patients included in the review had their index colonoscopy performed during 2002-2009, when they averaged about 61 years old, and about 95% were men. Their average Charlson comorbidity index was about 1.3. The incidence of colorectal cancer during follow-up after the index colonoscopy was 0.18% in patients with one or two nonadvanced adenomas in their index examination and no follow-up colonoscopy, 0.71% in those with nonadvanced adenomas who had one or more subsequent colonoscopies, and 0.31% in the people with no adenomas removed during the index procedure.
The rates of all-cause death during follow-up of the three subgroups were notably different: 34% in those with nonadvanced adenomas and no repeat colonoscopy, 13% in patients with nonadvanced adenomas and repeat colonoscopy, and 21% in those without nonadvanced adenomas. Dr. Imperiale discounted the significance of comparing rates of all-cause mortality, stressing that the most relevant primary endpoint is colorectal cancer mortality.
Dr. Imperiale reported having no disclosures.
[email protected]
On Twitter @mitchelzoler
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Colorectal cancer mortality was 0.13% in patients without follow-up colonoscopy and 0.16% in patients who had a second colonoscopy.
Data source: Review of 66,567 people at 13 U.S. VA Medical Centers.
Disclosures: Dr. Imperiale reported having no disclosures.